Clinical Research Associate
Department of Medicine, Rutgers New Jersey Medical School
Newark, New Jersey, United States · Tempo pieno
Sii il primo a candidarti
- Esperienza
- 3+ anni
- Stipendio
- —
- Aperture
- 1
- Pubblicato
- 11 ore fa
- Modalità di lavoro
- In ufficio
- Istruzione
- Master's degree
- Riprendere
- È necessario candidarsi
Dove lavorerai
Descrizione del lavoro
About the Position
The Department of Medicine at Rutgers New Jersey Medical School's Division of Infectious Diseases is seeking an experienced Clinical Research Associate. Rutgers Health, a comprehensive academic health center, fosters collaboration among multiple schools and centers focusing on innovative medical education, patient care, and advanced research to improve health outcomes. The Clinical Research Associate will join a multidisciplinary team dedicated to ensuring regulatory compliance in clinical research projects at Rutgers.
Primary Responsibilities
- Manage all regulatory coordination and ensure study compliance with FDA, Good Clinical Practice (GCP), OHRP, HIPAA, conflict of interest policies, Institutional Review Board (IRB), and institutional procedures outlined by Rutgers and study sponsors.
- Support investigators and study coordinators by assisting in the development and submission of IRB applications, consent forms, and related regulatory documents.
- Help prepare required regulatory and compliance documentation for grant applications, ensuring alignment with sponsor and institutional mandates.
- Lead the coordination and compilation of regulatory material for sponsor progress reports, including RPPR submissions, tracking necessary documentation and confirming regulatory status collaboratively with research teams.
- Organize protocol-specific regulatory binders, manage version control of protocols and informed consent forms (ICFs), and facilitate communication with sponsors and collaborators regarding regulatory matters.
Qualifications and Experience
- Master’s degree in a relevant field.
- A minimum of three years' research experience, including at least two years involving university-level regulatory affairs.
- Comprehensive knowledge of regulatory aspects related to human subjects protection, IRB processes, and informed consent.
- Proficiency in computer applications such as Microsoft Office and research databases.
- Strong attention to detail, organizational abilities, and excellent communication and interpersonal skills.
- Professional accountability and commitment to high standards of excellence.
- Preferred: Experience working within a university research environment.